BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 3052163 · Received April 11, 2013

    Report

    Report Number
    2183996-2013-00648
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE MOISTURE ENTERED THE INSULIN PUMP AND DESTROYS THE FUNCTIONALITY OF THE BUTTONS AND THE PUMP ELECTRONICS. THE UP BUTTON DOES NOT RESPOND TO COMMANDS DUE TO THE CONTAMINATION INSIDE THE BUTTON.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE SOFT COMPONENTS OF THE UP AND DOWN BUTTONS ON THE PATIENT'S INFUSION DEVICE WERE DETERIORATED AND TWO DAYS AGO THEY BEGAN TO ONLY FUNCTION INTERMITTENTLY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156246 ACCU-CHEK SPIRIT INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 028 YR